摘要
目的 系统评价环索奈德鼻喷剂治疗季节性过敏性鼻炎的临床疗效和安全性,为临床合理用药提供循证依据.方法 通过检索Cochrane library、Web of Science、Pubmed、ClinicalTrials、中国知网(CNKI)、万方、维普及中国生物医学数据库(CBM),收集比较环索奈德(试验组)和安慰剂(对照组)治疗过敏性鼻炎的随机对照试验,检索时限均为从建库至 2022 年 10月.由 2 位评价员按照纳入及排除标准对文献进行严格筛选,并进行质量评估,使用 RevMan5.4 版软件进行统计分析.结果 纳入 8 项研究的Meta分析结果显示,环索奈德具有降低瞬时总鼻症状评分[WMD=-0.43,95%CI(-0.63,-0.23),P<0.01]、瞬时鼻腔单项评分[WMD=-0.19,95%CI(-0.23,-0.05),P<0.01]、反映性总鼻症状评分[WMD=-0.66,95%CI(-0.80,-0.52),P<0.01]、反映性鼻腔单项评分[WMD=-0.23,95%CI(-0.26,-0.21),P<0.01]、瞬时眼部单项积分[WMD=-0.19,95%CI(-0.22,-0.15),P<0.01]、瞬时眼部症状总积分[WMD=-0.28,95%CI(-0.56,-0.00),P=0.05]、反映性眼部症状总积分[WMD=-0.27,95%CI(-0.54,-0.00),P=0.05]、反映性眼部单项积分[WMD=-0.17,95%CI(-0.21,-0.14),P<0.01]、鼻结膜炎生存质量量表[WMD=-0.61,95%CI(-0.76,-0.47),P<0.01]的相关评分的作用.试验组与对照组相比,不良反应事件的发生率[OR=0.96,95%CI(0.76,1.20),P=0.72]无变化.结论 环索奈德鼻喷剂对季节性过敏性鼻炎的治疗卓有成效,且不良反应事件的发生率无变化,有良好的安全性及耐受性,具有进一步临床推广的价值.
Abstract
Objective This study aimed to evaluate the clinical efficacy and safety of ciclesonide nasal spray in the treatment of sea-sonal allergic rhinitis and provide evidence-based guidelines for rational drug use.Methods Cochrane Library,Web of Science,PubMed,ClinicalTrials,China National Knowledge Infrastructure,WanFang,Chinese Scientific Journal,and Chinese Biomedical Databases were searched.Randomized controlled trials were collected to compare ciclesonide(trial groups)with placebo(control groups)for the treatment of allergic rhinitis.All RCTs were randomized from the establishment of the databases to October 2022.According to the inclusion and exclusion criteria,the literature was strictly screened by two evaluators.Additionally,the quality of the included studies was assessed.The Review Manager(version 5.4)software was used for statistical analyses.Results A total of 9 studies were included in this meta-analysis.In terms of efficacy,ciclesonide reduced instantaneous total nasal symptom score(weighted mean difference[WMD]=-0.43;95%convidence interval[CI;-0.63,-0.23];P<0.01)and instantaneous single nasal score[WMD=-0.19;95%CI(-0.23,-0.05);P<0.01].Ciclesonide also reduced the role of reflective total nasal symptom score[WMD=-0.66;95%CI(-0.80,-0.52)];P<0.01)and reflective nasal single score[WMD=-0.23;95%CI(-0.26,-0.21);P<0.01].It also reduced instantaneous ocular symptom score[WMD=-0.19;95%CI[-0.22,-0.15];P<0.01];instantaneous ocular symptom total score[WMD=-0.28;95%CI(-0.56,-0.00);P= 0.05];and reflective ocular symptom total score[WMD=-0.27;95%CI(-0.54,-0.00);P=0.05].Moreover,ciclesonide reduced mirrored ocular single score[WMD=-0.17;95%CI(-0.21,-0.14);P<0.01]and related scores of the rhinoconjunctivitis quality of life scale[WMD =-0.61;95%CI(-0.76,-0.47);P<0.01].Regarding safety,the incidence of adverse events was not increased in the experimental group compared with the control group[odds ratio=0.96;95%CI(0.76,1.20);P=0.72].Conclusion Ciclesonide nasal spray was effective in the treat-ment of seasonal allergic rhinitis.Furthermore,it did not increase the incidence of adverse events.Ciclesonide has been shown to have good safety and tolerance and the value of further clinical promotion.
NETL
NSTL
维普
万方数据